Valvular prosthesis

• US 20030149477A1
• Filed: 02/24/2003
• Published: 08/07/2003
• Est. Priority Date: 09/12/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Granted Patent: US 7,025,780 B2
• Time in Patent Office: Days
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A valvular prosthesis and method of using the prosthesis are disclosed. A valve apparatus is located within a stent apparatus, such that the prosthesis is deformable between a first condition and a second condition, in which the prosthesis has a reduced cross-sectional dimension relative to the first condition, whereby implantation of the prosthesis is facilitated when in the second condition.

Claims

1. A valvular prosthesis comprising:

a valve apparatus located within a stent apparatus to form a stented valve, the stented valve being deformable between a first condition a second condition, the stented valve having a cross-sectional dimension in the second condition that is less than a cross-sectional dimension of the stented valve when in first condition, whereby implantation of the stented valve is facilitated when in the second condition.

2. The prosthesis of claim 1, wherein the stent apparatus is formed of a shape memory alloy.

3. The prosthesis of claim 2, wherein the shape memory alloy is a nickel-titanium alloy material.

4. The prosthesis of claim 1, wherein the stent apparatus includes spikes extending generally radially outwardly from the stent apparatus for, when implanted within tissue, engaging the tissue to inhibit movement of the stented valve relative to the tissue.

5. The prosthesis of claim 1, in combination with a retaining element to retain the stented valve in the second condition.

6. The combination of claim 5, wherein the retaining element includes an enclosure in which at least a substantial portion of the prosthesis is disposed to maintain the stented valve in the second condition.

7. The combination of claim 6, wherein the enclosure is part of a catheter system adapted to position an opening of the enclosure at a desired position and to discharge the prosthesis from the enclosure, such that the stented valve expands toward the first condition.

8. The prosthesis of claim 1 wherein the valve apparatus further comprises a animal heart valve.

9. The prosthesis of claim 8, wherein the valve apparatus further comprises an animal venous valve.

10. The prosthesis of claim 1, wherein the valve apparatus is cross-linked with glutaraldehyde and substantially detoxified.

11. The prosthesis of claim 1, wherein each of the valve apparatus and the stent apparatus has a generally sinusoidal outflow end.

12. The prosthesis of claim 11, wherein a sheath of a substantially biocompatible material covers the stent apparatus and at least a portion of the valve.

13. The prosthesis of claim 12, wherein the sheath has an outflow end contoured according to the outflow end of the valve, with a plurality of lobes extending axially therefrom beyond an outflow edge of the valve.

14. The prosthesis of claim 11, wherein the stent apparatus further includes a plurality of stent posts extending from a stent base portion radially outwardly and generally toward the outflow end of the valve.

15. The prosthesis of claim 1, wherein the stent apparatus is formed of a deformable mesh material compressible to the second condition and expandable to the first condition.

16. The prosthesis of claim 1, wherein the stent apparatus has an annular base portion at an inflow end thereof, a plurality of spikes arranged in at least two axially spaced apart rows extending generally radially outwardly from the stent apparatus for, when implanted within tissue, engaging the tissue to inhibit movement of the stented valve relative to the tissue.

17. The prosthesis of claim 16 further including a sheath of a substantially biocompatible material covering the stent apparatus and at least a portion of the valve, the spikes extending through the sheath.

18. A method for implanting a valvular prosthesis having a valve apparatus mounted within a stent apparatus, comprising the steps of:

reducing a cross-sectional dimension of the valvular prosthesis to a first condition;

positioning the valvular prosthesis at a desired position within a length of tubular tissue while in the first condition; and

increasing the cross-sectional dimension of the valvular prosthesis to a second condition, such that a portion of the valvular prosthesis engages the tubular tissue to mitigate axial movement of the prosthesis relative to the tubular tissue.

19. The method of claim 18 further including the step of positioning the valvular prosthesis while in the first condition within an enclosure to maintain the first condition.

20. The method of claim 19 further including the step of discharging the valvular prosthesis from the enclosure to initiate the step of increasing.

21. The method of claim 18, wherein the tubular tissue is an aorta.

22. The method of claim 18, wherein the tubular tissue is a pulmonary artery.

23. The method of claim 18, wherein the tubular tissue is a vein.

24. A valvular prosthesis comprising:

valve means for permitting substantially unidirectional flow of fluid through the valve means; and

stent means disposed about the valve means for supporting the valve means, the stent means and valve means being deformable between a first condition a second condition, in which the prosthesis has a cross-sectional dimension that is less than a cross-sectional dimension thereof when in the first condition, whereby implantation of the prosthesis is facilitated when the stent means and valve means are in the second condition.

25. The prosthesis of claim 24 further including means for retaining the prosthesis in the second condition, the prosthesis being dischargeable from the means for retaining.